U.S. patent number 7,628,774 [Application Number 11/416,880] was granted by the patent office on 2009-12-08 for needleless medical connector.
This patent grant is currently assigned to ICU Medical, Inc.. Invention is credited to Thomas F. Fangrow, Jr..
United States Patent |
7,628,774 |
Fangrow, Jr. |
December 8, 2009 |
**Please see images for:
( Certificate of Correction ) ** |
Needleless Medical Connector
Abstract
A valve for selectively permitting a fluid flow between first
and second medical implements is disclosed. The valve has a housing
with an interface suitable for receiving a connector portion of a
first medical device such as a catheter, and a seal made of a
flexible material. The seal has a first end in fluid communication
with the interface, a second end suitable for receiving the second
medical device, and at least one slit in fluid communication with
the first end and the second end. The slit defines a restricted
fluid flow path and a relatively small interior volume when in an
undisturbed state, defines an expanded fluid flow path and a larger
interior volume upon the introduction of the second medical
instrument into the slit, and retracts to define a restricted flow
path and a small interior volume upon the withdrawal of the second
medical device from the seal.
Inventors: |
Fangrow, Jr.; Thomas F.
(Mission Viejo, CA) |
Assignee: |
ICU Medical, Inc. (San
Clemente, CA)
|
Family
ID: |
24459496 |
Appl.
No.: |
11/416,880 |
Filed: |
May 2, 2006 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20060212000 A1 |
Sep 21, 2006 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
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11157216 |
Jun 20, 2005 |
|
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10636163 |
Aug 7, 2003 |
6916309 |
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09614001 |
Jul 11, 2000 |
6695817 |
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Current U.S.
Class: |
604/247;
604/167.06; 604/167.04; 604/167.03; 604/167.01; 285/283;
251/149.1 |
Current CPC
Class: |
A61M
39/02 (20130101); A61M 39/0247 (20130101); A61M
39/06 (20130101); A61M 39/045 (20130101); A61M
39/10 (20130101); A61M 39/26 (20130101); A61M
2039/0205 (20130101); A61M 2039/027 (20130101); A61M
2039/062 (20130101); A61M 2039/0258 (20130101); A61M
2039/263 (20130101) |
Current International
Class: |
A61M
5/00 (20060101) |
Field of
Search: |
;604/167.01,167.02,167.03,167.04,167.05,167.06,247,249 ;285/283
;251/149.1,149.4,149.6 |
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Order Granting Defendant ICU's Motion for Summary Judgment of
Noninfringement; Entered Sep. 14, 2007 in Case No. SA CV 06-619.
cited by other .
Expert Report of Paul DiPema regarding Inequitable Conduct and
Invalidity, Filed in Case No. SA CV 06-619 MRP ANx dated Sep. 17,
2007. cited by other .
Declaration of Paul DiPema in Support of ICU's Claim Construction
Brief, Filed in Case No. Sa CV 06- 619 MRP ANx; (Exhibit C to the
Expert Report of Paul DiPerna regarding Inequitable Conduct and
Invalidity). cited by other .
Claim Chart Disclosing Location of Limitations in Prior and
Motivations to Combine (Exhibit D to the Expert Report of Paul
DiPerna regarding Inequitable Conduct and Invalidity). cited by
other .
Summary Listing why Prior Art Considered by the Examiner is not
Cumulative to Peppel, Rogers, Frank, and Collinson; (Exhibit E to
the Expert Report of Paul DiPerna regarding Inequitable Conduct and
Invalidity). cited by other .
Declaration of Alison D. Burcar in Support of ICU's Claim
Construction Brief, Filed in Case No. SA CV 06-619 MRP ANx;
(Exhibit G to the Expert Report of Paul DiPerna regarding
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Extended European Search Report for Application No. 08014856.2
dated Jan. 26, 2009. cited by other.
|
Primary Examiner: Tran; Binh Q
Attorney, Agent or Firm: Knobbe, Martens, Olson & Bear,
LLP
Parent Case Text
RELATED APPLICATIONS
This application is a continuation of U.S. patent application Ser.
No. 11/157,216, filed Jun. 20, 2005, pending, which is a
continuation of U.S. patent application Ser. No. 10/636,163, filed
Aug. 7, 2003, now U.S. Pat. No. 6,916,309, which is a continuation
of U.S. patent application Ser. No. 09/614,001, filed Jul. 11,
2000, now U.S. Pat. No. 6,695,817, all of which are incorporated
herein by reference in their entireties.
Claims
What is claimed is:
1. A needleless medical connector having a downstream end for
receiving a first medical device and an upstream end for receiving
a second medical device having a standard medical Luer tip, the
medical connector comprising: a housing having an interface
configured to receive a connector portion of the first medical
device, the housing comprising an upstream end, a downstream end, a
cavity extending from the upstream end of the housing to a lower
inner surface of the housing, and a lead cannula extending from the
lower inner surface toward the upstream end of the housing, the
lead cannula having a substantially cylindrical outer surface and
an inner diameter of the lead cannula being similar in size to an
inner diameter of an end of the second medical device; and a seal
element having a downstream end in fluid communication with the
interface, an upstream end suitable for receiving the second
medical device, and a normally substantially closed passage in
fluid communication with the downstream end and the upstream end of
the seal element such that a substantial portion of the end of the
second medical device is permitted to enter the passage when the
second medical device is inserted into the medical connector,
wherein the downstream end of the seal element is permitted to
slide along the outer surface of the lead cannula and to move
toward the lower inner surface of the housing when the second
medical device is inserted into the medical connector; wherein the
medical connector is configured so that upon full insertion of the
second medical device into an upstream end of the passage, a
distance between a lead surface of the Luer tip of the second
medical device and an upstream end of the lead cannula is
approximately the same size as an inner diameter of the lead
cannula; and wherein the upstream end and the downstream end of the
medical connector are disposed on substantially the same axis to
assist in providing a substantially straight fluid- flow path.
2. The medical connector of claim 1, wherein the interface of the
housing comprises a Luer lock interface.
3. The medical connector of claim 1, wherein the housing comprises
an axial opening at the upstream end of the housing and at least
one side opening.
4. The medical connector of claim 1, wherein the housing comprises
two protrusions positioned near the upstream end thereof, the
protrusions configured to threadably engage the second medical
device.
5. The medical connector of claim 1, wherein the medical connector
is configured to selectively permit a substantially unobstructed,
smooth flow of fluid therethrough.
6. The medical connector of claim 1, wherein the housing comprises
a seal holder containing the seal element such that the interface
is configured to be mateably coupled to the seal holder.
7. The medical connector of claim 1, wherein the lead cannula
comprises a lumen therethrough, and wherein the downstream end of
the seal element is in fluid communication with the lumen of the
lead cannula.
8. The medical connector of claim 1, wherein upon insertion of the
second medical device into an upstream end of the passage, the
distance between the end of the second medical device and the
upstream end of the lead cannula is less than the height of the
lead cannula.
9. The medical connector of claim 1, wherein upon insertion of the
second medical device into an upstream end of the passage, the
distance between the end of the second medical device and the
upstream end of the lead cannula is similar in size to the inner
diameter of the end of the second medical device.
10. The medical connector of claim 1, wherein the housing is
substantially rigid.
11. The medical connector of claim 1, wherein the seal element
further comprises a substantially planar slit defining a highly
restricted flow path in an undisturbed state, and a substantially
unobstructed linear flow path when the second medical device is
inserted into the passage.
12. The medical connector of claim 1, wherein the seal element
comprises a body made of flexible material and having a downstream
end and an upstream end opposite the downstream end, a lead lumen
formed in the downstream end of the body and in fluid communication
with the passage, a neck formed at the upstream end of the body,
and a transverse flange at an end of the neck opposite the body,
wherein the transverse flange has at least one opening in fluid
communication with the passage.
13. The medical connector of claim 1, wherein upon insertion of the
second medical device into an upstream end of the passage, the seal
element is moved downward onto the lead cannula such that at least
a portion of the lead cannula extends into the passage.
14. The medical connector of claim 1, wherein the passage has a
relatively small interior volume when in an undisturbed state and a
larger volume upon introduction of the second medical device into
an upstream end of the passage, the passage retracting to define a
restricted flow path and a relatively small interior volume upon
withdrawal of the second medical device from the seal element, the
upstream end of the passage initially being sealed as the second
medical device is withdrawn so that fluid occupying the interior
volume is forced toward a downstream end of the passage as the
passage retracts.
15. The medical connector of claim I, wherein the seal element is
made of silicone rubber.
16. The medical connector of claim 1, wherein the seal element is
made of synthetic polyisoprene.
17. The medical connector of claim 1, wherein the housing comprises
at least one slit extending generally vertically from an end of the
housing opposite the interface toward the interface.
18. The medical connector of claim 17, wherein the slit of the
housing permits the housing to expand upon insertion of the second
medical device into the seal element.
19. The medical connector of claim 18, wherein the housing expands
in a manner that permits the second medical device to be retained
in the seal element.
20. The medical connector of claim 19, wherein the second medical
device comprises a medical device having a Luer slip connector.
21. The medical connector of claim 17, wherein the housing
comprises an axial opening at an end opposite the interface and at
least one side opening.
22. The medical connector of claim 21, wherein the at least one
slit extends from the axial opening to the at least one side
opening.
23. The medical connector of claim 1, wherein the downstream end of
the seal element is permitted to move away from the lower inner
surface of the housing when the second medical device is removed
from the medical connector.
24. The medical connector of claim 1, wherein at least a portion of
the seal element closely fits about the outer surface of the lead
cannula proximal an upstream opening in the lead cannula when the
second medical device is inserted into the medical connector.
25. The medical connector of claim 1, wherein the lead cannula is
substantially rigid.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates generally to a medical valve, and in
particular to a valve which, when connected between a first medical
device, such as a fluid source, and a second medical device, such
as a catheter, facilitates fluid flow therebetween, and when the
first medical device is disconnected therefrom, induces a positive
flow of fluid through the valve in the direction of the second
medical device.
2. Description of the Related Art
The manipulation of fluids for parenteral administration in
hospitals and medical settings routinely involves the use of
connectors and valves for selectively facilitating the movement of
fluids between two points. These valves are typically placed along
a fluid flow line leading to a patient or other destination. For
example, the tube may lead to a catheter having its tip positioned
within a patient.
The valve is arranged so that a fluid source or other line may be
connected thereto for providing a fluid flow from the source to the
patient. When the fluid source or line is removed, the valve
closes, sealing the line leading to the patient.
The element which is connected to the valve may comprise a tube or
other medical device such as a conduit, syringe, IV set (both
peripheral and central lines), piggyback line, or similar component
which is adapted for connection to the medical valve.
Unfortunately, prior art valves suffer from a problem arising from
the disconnection of these medical devices from the valve.
These valves define a space within them through which a fluid or
other material may flow from the device to the line on which the
valve is mounted. When the medical device is connected to the
valve, it typically occupies a portion of this internal valve
space, displacing the fluid (whether it be a liquid or air) within
the valve.
A problem arises when the medical device is disconnected from the
valve. When the device is disconnected, it no longer occupies a
portion of the space in the valve. The increase in space within the
valve causes the fluid in the valve and line to which the valve is
connected, to move to fill the space. In effect, the removal of the
device creates a suction force which draws fluid into the
valve.
In the medical setting, this movement of fluid is very undesirable.
When the valve is connected to a fluid line leading to a patient,
the movement of fluid through the line towards the space in the
valve has the effect of drawing blood from the patient in the
direction of the valve. A serious problem may result in that this
blood may clot and clog the catheter near its tip, rendering it
inoperable, and may even result in a clot of blood in the patient,
which may prove fatal.
One attempt at overcoming this clogging problem has been to coat
the inner surface of the catheter near its tip in order to prevent
blood from sticking to its interior surfaces. This method has
generally been unsuccessful in preventing clogging of the
catheter.
The risk of blood clogging of the catheter is significantly
heightened where the inner diameter of the catheter is small (e.g.,
27 gauge). These small catheters have the advantage, however, in
that they reduce the trauma and discomfort caused by insertion into
a patient. Because these catheters have a very small passage
therethrough, even a small suction force may draw sufficient amount
of fluid back through a catheter toward the valve to introduce
blood into the catheter tip, which blood may clog the catheter's
passage.
Overcoming the above-stated problem is made more difficult when
considering other criteria which the valve must satisfy. For
example, the valve should be arranged to so that it does not have
any fluid stagnation points. If the fluid is allowed to stagnate in
one or more areas of the valve, bacteria growth and other problems
may occur.
In addition, the valve should have an internal flow path which is
smooth. Sharp edges and corners may damage blood cells and cause
hemolysis.
A valve that overcomes the above-stated problems is desired.
SUMMARY OF THE INVENTION
In accordance with one preferred embodiment, a medical valve for
selectively permitting fluid to flow between a first medical device
and a second medical device comprises a housing that has an
interface suitable for receiving a connector portion of the first
medical device, and a seal. The seal is made of a flexible material
and has a downstream end in fluid communication with the interface,
an upstream end suitable for receiving the second medical device,
and a normally substantially closed passage in fluid communication
with the downstream end and the upstream end. The passage has a
relatively small interior volume when in an undisturbed state and a
larger interior volume upon the introduction of the second medical
instrument into the upstream end of the passage. The passage
retracts to define a restricted flow path and a relatively small
interior volume upon the withdrawal of the second medical device
from the seal (the upstream end initially being sealed as the
second medical device is withdrawn) so that a fluid occupying the
interior volume is forced toward the downstream end as the passage
walls collapse.
In accordance with another preferred embodiment there is provided a
valve seal for use in a medical valve having an interface for fluid
communication with a first medical device. The seal comprises a
first end in fluid communication with the interface, a second end
suitable for receiving a second medical device, and at least one
slit in fluid communication with the first end and the second end.
The slit defines a restricted fluid flow path and a relatively
small interior volume when in an undisturbed state, and defines an
expanded fluid flow path and a larger interior volume upon the
introduction of the second medical device into the slit. The slit
retracts to define a restricted flow path and a relatively small
interior volume upon the withdrawal of the second medical device
from the seal.
In accordance with another preferred embodiment a method is
provided for causing a positive flow in the direction of a first
medical device from a valve that connects the first medical device
to a second medical device and has an associated seal. The seal is
adapted to receive at least a portion of the second medical device
and provide fluid communication between the first and second
medical devices. The method comprises the steps of withdrawing the
second medical device from the seal and
permitting the seal to retract from a large interior volume to a
relatively small interior volume so as to displace any fluid within
the seal in the direction of the first medical device.
In accordance with another preferred embodiment there is provided a
method of preventing blood from flowing out of a patient into a
catheter when a syringe is withdrawn from a valve between the
syringe and the catheter. The method comprises the steps of
connecting the downstream end of the valve to the catheter and
inserting the end of the syringe into a slit forming the upstream
end of a normally substantially closed seal passage that is located
in a resilient seal and is in fluid communication with the
downstream end of the valve. This causes the seal passage to open
while providing sealing contact between the syringe and the
upstream end of the seal passage. The method further comprises the
steps of injecting fluid from the syringe through the seal passage
to the catheter and into the patient, and withdrawing the syringe,
allowing the walls of the seal passage to return to their
substantially closed position while initially maintaining sealing
contact between the upstream end and the syringe. This provides a
force urging fluid in the passage toward the catheter.
In accordance with another preferred embodiment there is provided a
medical valve for selectively permitting fluid to flow between a
first medical device and a second medical device through an
associated seal. The valve comprises an interface suitable for
receiving a connector portion of the first medical device, and a
seal holder in fluid communication with the interface.
In accordance with another preferred embodiment a system for
administering fluid to a blood vessel of a patient comprises a
catheter having an upstream end and a downstream end that is
suitable for placement in fluid communication with the blood
vessel, and a syringe suitable for expelling fluid into the
catheter. The system further comprises a valve having a fitting
suitable for connection to the upstream end of the catheter and
providing selective fluid communication between the syringe and the
catheter. The valve further comprises a seal made of a flexible
material. The seal has a downstream end in fluid communication with
the fitting, an upstream end suitable for receiving the syringe,
and a normally substantially closed passage in fluid communication
with the downstream end and the upstream end. The passage has a
relatively small interior volume when in an undisturbed state and a
larger interior volume upon the introduction of the syringe into
the upstream end of the passage. The passage retracts to define a
restricted flow path and a relatively small interior volume upon
the withdrawal of the second medical device from the seal (the
upstream end initially being sealed as the syringe is withdrawn),
so that a fluid occupying the interior volume is forced toward the
downstream end as the passage walls collapse.
In accordance with another preferred embodiment there is provided a
method of making a medical valve seal of the type having a body
made of a flexible material and at least one slit formed within the
body between adjacent first and second slit walls. The method
comprises molding first and second preforms, each preform
comprising one of the first and second slit walls and a perimeter
edge portion, and pressing the first and second preforms together
so that the first and second slit walls face each other. The method
further comprises molding an additional amount of a flexible
material to at least part of the perimeter edge portions of the
first and second preforms so that the first and second preforms and
the additional material form a unitary mass with the slit formed
therein.
For purposes of summarizing the invention and the advantages
achieved over the prior art, certain objects and advantages of the
invention have been described herein above. Of course, it is to be
understood that not necessarily all such objects or advantages may
be achieved in accordance with any particular embodiment of the
invention. Thus, for example, those skilled in the art will
recognize that the invention may be embodied or carried out in a
manner that achieves or optimizes one advantage or group of
advantages as taught herein without necessarily achieving other
objects or advantages as may be taught or suggested herein.
All of these embodiments are intended to be within the scope of the
invention herein disclosed. These and other embodiments of the
present invention will become readily apparent to those skilled in
the art from the following detailed description of the preferred
embodiments having reference to the attached figures, the invention
not being limited to any particular preferred embodiment(s)
disclosed.
BRIEF DESCRIPTION OF THE DRAWINGS
Having thus summarized the general nature of the invention and its
essential features and advantages, certain preferred embodiments
and modifications thereof will become apparent to those skilled in
the art from the detailed description herein having reference to
the figures that follow, of which:
FIG. 1 is a schematic view of the use of a valve in accordance with
the invention to interconnect a catheter with a fluid source such a
syringe;
FIG. 2 is a perspective view of the valve;
FIG. 3 is a front elevation view of the valve;
FIG. 4 is a side elevation view of the valve;
FIG. 5 is a perspective view of a seal for use in the valve;
FIG. 6A is a front-elevation view of the seal;
FIG. 6B is a front cross-sectional view of the seal;
FIG. 7A is a side elevation view of the seal;
FIG. 7B is a side cross-sectional view of the seal;
FIG. 8A is a front elevation view of the seal;
FIGS. 8B 8D are cross-sectional schematic views of the insertion of
a medical device into the seal taken through lines 8B--8B, 8C--8C
and 8D--8D of FIG. 8A, respectively;
FIG. 9 is a front cross-sectional view of a housing for use in the
valve;
FIG. 10 is a side cross-sectional view of the valve and the syringe
before insertion of the syringe into the valve;
FIG. 11 is a side cross-sectional view of the valve with the
syringe fully inserted;
FIG. 12 is a front cross-sectional view of the valve with the
syringe fully inserted;
FIG. 13 is a side cross-sectional view of the valve with the
syringe partly withdrawn;
FIG. 14 a side cross-sectional view of the valve with the syringe
further withdrawn in comparison to FIG. 13;
FIG. 15 is a side elevation view of an alternative embodiment of
the valve, with the syringe partly inserted;
FIG. 16 is a side elevation view of an alternative embodiment of
the valve, with the syringe fully inserted;
FIG. 17 is a front elevation view of the valve as used with a
syringe having a Luer lock;
FIG. 18 is a side elevation view of an alternative embodiment of
the valve housing;
FIGS. 19A 19E are schematic views of a process of making the seal;
and
FIG. 20 is a plan view of an overmold plate used in making the
seal.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
FIGS. 1 9 depict a valve 20 in accordance with a preferred
embodiment of the invention. FIG. 1 illustrates a particular use of
the valve 20 to which it is well suited. Of course, the valve 20
may be used in a variety of other manners.
As illustrated in FIG. 1, the valve 20 may advantageously be used
to selectively control the flow of fluid to a first medical device
(such as a catheter 22 shown here) from a second medical device
(generally comprising a fluid source such as an ISO standard
syringe 24). In this arrangement, the catheter 22 is connected to
one end of the valve 20 and has a tip 26 inserted into the arm of a
patient. The syringe 24 has a cannula tip or Luer 28 that is
inserted into the other end of the valve 20, which is designed to
accept the Luer 28 of the syringe 24 without a needle installed on
the Luer.
When so connected, the valve 20 permits fluid to flow from the
syringe 24 to the catheter 22 and into the patient. The valve 20 is
also arranged so that when the syringe 24 is disconnected, fluid
flow through the valve 20 is prevented. In addition, when the
syringe 24 is disconnected, the valve 20 generates a "positive"
fluid flow, i.e. flow of fluid in the direction of the patient,
thereby preventing blood from entering the catheter 22 and causing
the associated adverse effects.
FIGS. 2 4 depict one preferred embodiment of a valve 20 in
accordance with the invention. The valve 20 comprises a relatively
rigid housing 30 and a relatively flexible and resilient seal 32
disposed on or within the housing 30. The housing 30 has a Luer
lock interface 34 at its lower end to facilitate connecting the
valve 20 to a variety of medical devices. One skilled in the art
will readily appreciate that a number of other interface or
connection types are suitable for use in place of the Luer lock 34,
such as a Luer slip connection or a barbed hose fitting.
The seal 32 has a slit opening 36 (best seen in FIG. 2) which is
configured to permit the Luer 28 of a syringe 24 (see FIG. 1) to
enter the seal 32 upon application of moderate pressure by the
user. The syringe Luer 28 thus enters a slit 38 (see FIG. 3) formed
in the interior of the seal 32. With the syringe Luer 28 thus
inserted, the seal permits fluid ejected from the syringe 24
through the Luer 28 to flow through the slit 38 and Luer lock 34
and into the catheter 22 or other medical device attached to the
Luer lock 34.
FIGS. 5 7B show the seal 32 removed from the housing for purposes
of clarity. The seal 32 has a body 40 which may take the form of a
slab having a flat, generally rectangular shape. Like the entirety
of the seal 32, the body 40 is preferably formed of molded, 50
durometer silicone rubber, or is alternatively formed of synthetic
polyisoprene. At one end of the body 40 is formed a flat, generally
rectangular neck 42 and a generally circular transverse flange 44.
The neck 42 is situated between first and second lateral extensions
43a, 43b which have shoulders 43c, 43d comprising those portions of
the lateral extensions nearest the flange 44. The body 40, neck 42
and flange 44 thus form an integral unit, inside of which is formed
the (preferably substantially planar) slit 38. The slit 38 extends
from the slit opening 36 (best seen in FIG. 2) in the flange 44 to
a lead lumen 46 formed in an end of the body 40 opposite the flange
44. The lead lumen 46 is preferably substantially cylindrical and
centered about an axis that is substantially parallel to or
collinear with the longitudinal axis of the seal. The slit 38 is
preferably substantially planar and of virtually no thickness
unless a Luer is connected. The slit 38 thus forms (in its
undisturbed state, i.e. when the syringe Luer 28 has not been
inserted into the seal 32) a highly restricted fluid flow path from
the slit opening 36 to the lead lumen 46. As used herein in
reference to a flow path, "restricted" means a flow path that
permits either no fluid, or a clinically negligible amount of
fluid, to pass.
The preferred configuration of the slit 38 and lead lumen 46 is
best seen in FIGS. 6A 7B. The slit 38 has a body portion 48 within
the body 40 of the seal 32. Advantageously, the body portion 48 is
a region of maximum width, preferably about 0.228'', of the slit
38. The slit 38 tapers to a point or region 50 of minimum width,
which is preferably located within the neck 42. Advantageously, at
the region 50 of minimum width the slit 38 is preferably about
0.120'' wide. In other words, the width of the slit 38 in the body
portion 48 is almost twice that of the region 50 of minimum width.
From the region 50 of minimum width the slit 38 tapers outward to
the slit opening 36, where it attains a preferred width of about
0.200''. This tapered configuration acts as lead-in for insertion
of the syringe Luer 28 into the slit 38. The slit 38 may also have
beveled corners 52 at its lower end, opposite the neck 42. At its
lower end the slit 38 connects to the lead lumen 46 to facilitate
fluid communication between the slit 38 and the lead lumen 46. The
lead lumen 46 preferably has a lead-in chamfer 54 and a beveled
transition 56 to the slit 38. The preferred inside diameter of the
lead lumen 46 is about 0.040''.
In the side views of FIGS. 7A and 7B, it may be seen that the seal
32 has a T-shaped cross section before installation in the housing
30, with the flange 44 forming the cross portion of the "T". Viewed
from the side, the slit 38 is uniformly thin, i.e. of no or
virtually no thickness, as it runs from the top of the seal 32 to
the lead lumen 46. However, upon installation in the housing 30,
the thickness of the slit 38 (when viewed from the side) will vary
somewhat as will be explained in greater detail below.
FIGS. 8A 8D show the effects, in terms of sealing performance, of
the varying width of the slit 38 after introduction of a syringe
Luer 28 into the slit 38. (The syringe Luer 28 is not shown in FIG.
8A for purposes of clarity.) FIG. 8B shows the arrangement of the
slit 38 and the syringe Luer 28 at the region 50 of minimum width,
when the Luer 28 has been fully inserted into the slit 38. Due to
the relative narrowness of the slit 38 at the region 50, the slit
38 draws up against substantially the entire perimeter of the
syringe Luer 28 at that location, creating a relatively tight
perimeter seal between the slit 38 and the Luer 28. In other words,
the perimeter of the open slit 38 at the region 50 is less than the
circumference of the Luer 28.
FIGS. 8C and 8D show that where the slit 38 is wider (i.e., in the
body portion 48 of the slit and the transition from the region 50)
the slit no longer contacts the entire perimeter of the syringe
Luer 28, leaving gaps 57 on one or both sides and the end of the
Luer 28. In other words, the perimeter of the open slit in the body
portion 48 is greater than the circumference of the Luer 28. As
will be discussed in greater detail below, this arrangement of a
slit-Luer seal near the top of the slit 38 and a fluid-occupiable
volume (in the form of the gaps 57) below the slit-Luer seal,
promotes a positive-flow function for the valve 20 when the syringe
Luer 28 is withdrawn.
FIGS. 3, 4, and 9 show a preferred configuration of the housing 30
and the installation of the seal 32 therein. The housing 30 is
preferably formed of molded polycarbonate, or alternatively formed
from any suitable thermoplastic. The housing 30 has a seal holder
58 attached to the Luer lock 34; the seal holder preferably has a
cylindrical configuration, but may comprise any shape or
construction sufficient to hold the seal 32 on or in the housing 30
without interfering with operation of the valve 20. The seal holder
has an axial opening 60 opposite the Luer lock 34, and first and
second side openings 62a, 62b which have first and second top edges
63a, 63b that comprise the edges of the side openings nearest the
axial opening 60. A lead cannula 64 (best seen in FIG. 9) extends
from the Luer lock 34 toward the axial opening 60 and contains an
internal lumen 66 which is in fluid communication with a lumen 68
in the Luer lock 34. The lead cannula 64 is preferably
substantially cylindrical or frusto-conical in shape and centered
about an axis that is substantially parallel to or collinear with
the longitudinal axis of the housing 30. A pair of lugs 70 are
positioned on the end of the seal holder 58 near the axial opening
60, to permit a Luer lock or other threaded connection (not shown)
to threadably engage the housing 30 at the axial opening 60.
As best seen in FIGS. 3 and 4, most of the seal 32 is situated
within the seal holder 58, with the first and second lateral
extensions 43a, 43b of the seal 32 protruding from the first and
second side openings 62a, 62b. The lead lumen 46 of the seal 32 is
situated so that the lead cannula 64 extends at least partway into
the lead lumen, facilitating fluid communication between the seal
32 and the Luer lock 34. The flange 44 covers the axial opening 60
and contacts the adjacent edges of the opening. Preferably, the
distance between the axial opening 60 and the top edges 63a, 63b of
the side openings 62a, 62b is slightly larger than the distance
between the flange 44 and the shoulders 43c, 43d of the lateral
extensions 43a, 43b. This arrangement results in the application of
a tensile force or preload to the seal 32 between the flange 44 and
the lateral extensions 43a, 43b. The preload arises as the
shoulders 43c, 43d bear against the top edges 63a, 63b and the
flange 44 bears against the edges of the axial opening 60. The
preload causes the flange 44 to assume a slightly bowl-shaped or
concave configuration as the edges of the axial opening 60 bear
against the underside of the flange 44. The bowl-shaped flange 44
thus serves as a lead-in for the insertion of the syringe Luer 28
into the slit opening 36 (best seen in FIG. 2), and tends to pinch
closed the slit opening 36 and thus enhances the ability of the
seal 32 to prevent fluid flow. The preload also prevents buckling
of the seal along its longitudinal axis and maintains the sides of
the slit 38 in close proximity along their entire length. The
preload thus promotes a relatively thin slit below the flange 44,
which enhances the sealing performance of the slit 38.
FIGS. 10 14 illustrate the function of the valve 20 as a syringe
Luer 28 is inserted into and withdrawn from the slit 38. FIG. 10
shows the valve 20 prior to insertion of the syringe Luer 28; at
this point the slit 38 defines a substantially closed or highly
restricted flow path through the seal 32, marked by a very thin (or
substantially nonexistent) path thickness T.sub.min between slit
walls 72a, 72b. This thin or nonexistent path thickness T.sub.min
prevails along most or substantially all of the length of the slit
38 below the flange 44. This condition restricts fluid flow through
the seal 32 so as to seal off the catheter 22 (see FIG. 1) or other
medical device connected to the Luer lock 34. At this point the
slit 38 also defines a relatively small interior volume V.sub.min
within the seal 32, between the slit walls 72a, 72b. (As used
herein in reference to an interior volume of the seal, "relatively
small" means a volume that is either nonexistent or clinically
negligible in size.) In this initial state, the seal 32 is situated
upon the lead cannula 64 such that substantially none of the lead
cannula 64 extends into the slit 38.
FIGS. 11 and 12 show the valve 20 after the syringe Luer 28 has
been completely inserted into the slit 38. The seal 32 has also
been stretched or forced downward onto the lead cannula 64, at
least part of which penetrates into the slit 38 itself. At this
point the slit 38 defines an expanded flow path through the seal
32, in that the slit walls 72a, 72b have spread to a path width
T.sub.max. The seal 32 thus permits fluid to flow between the
syringe 24 and the catheter 22. In addition, the slit 38 now
defines a larger or maximum interior volume V.sub.max. V.sub.max
comprises the entire space between the slit walls 72a, 72b less the
volume taken up by the cannula (but not the internal lumen) of the
syringe Luer 28 and less that portion of the lead cannula 64 which
has penetrated into the slit 38. Accordingly, under pressure
exerted via the syringe 24 an amount of fluid substantially
equivalent to V.sub.max now fills the slit 38 between the slit
walls 72a, 72b. This is also shown as gaps 57 in FIGS. 8C and
8D.
FIGS. 13 and 14 show the function of the slit 38 as the syringe
Luer 28 is withdrawn from the valve 20. As the syringe Luer 28 and
lead cannula 64 exit the slit, the slit walls 72a, 72b retract to
substantially their original configuration to once again define a
narrow path width (approaching T.sub.min) between them. This
retraction of the slit walls 72a, 72b reduces the volume between
the walls; that is, the internal volume within the slit 38 is
decreasing from V.sub.max. Thus the amount of fluid within the slit
must also decrease from V.sub.max. Accordingly, the retracting slit
walls 72a, 72b displace the fluid from the slit 38 as the syringe
Luer 28 is withdrawn.
The fluid thus displaced cannot flow out of the slit 38 through the
top of the seal 32. As detailed above with regard to FIGS. 8A 8B,
the slit 38 maintains a tight seal against the syringe Luer 28 at
the region 50 of minimum width as the syringe Luer 28 is withdrawn.
In addition, the displaced fluid cannot flow into the interior of
the syringe 24 at all times relevant to the use of the valve 20.
Therefore, substantially all of the displaced fluid must exit the
slit 38 through the lead cannula 64 and Luer lock 34, resulting in
positive flow from the valve 20 upon withdrawal of the syringe Luer
28.
FIGS. 15-18 show variations on the valve 20 disclosed above, which
variations may be desirable under certain operating conditions. For
example, as seen in FIGS. 15 and 16 the housing 30 may have a break
74 running vertically between the axial opening 60 and one or both
of the side openings 62a, 62b. The break 74 permits the seal holder
58 to spread open as a Luer slip 28 (as opposed to a Luer lock 76
shown in FIG. 17) is inserted into the seal 32. This spreading
action has been found to be advantageous for using the valve 20
with a Luer slip 28, as the valve 20 becomes less likely to squeeze
or pinch the Luer 28 out of the seal 32. As illustrated in FIG. 16,
upon full insertion of a portion of an end of the Luer 28 into the
seal 32, a distance between a lead surface of the Luer 28 and an
upstream end of the lead cannula 64 of the housing 30 may be
approximately the same size as an inner diameter of the lead
cannula 64 at the upstream end of the lead cannula 64. Also, as
shown in FIG. 16, the inner diameter of the lead cannula 64 at the
upstream end of the lead cannula 64 of the housing 30 may be
similar in size to an inner diameter of an end of the Luer 28.
FIG. 18 shows an alternative configuration of the housing 30, with
a curved or streamlined appearance in comparison to the housing
disclosed above. Both this type of housing or the type disclosed
above, may have an external coating or layer of a relatively soft,
pliant material such as a thermoplastic elastomer to enhance
operator comfort and to promote the theme of a valve 20 that
provides a connection without the use of sharp, puncturing elements
such as needles or blades.
FIGS. 19A 21 depict a preferred method of making the seal 32.
First, a pair of preforms 202a, 202b are molded between first and
second mold pairs 204a, 204b and 206a, 206b respectively. Each
preform 202 has a generally planar portion 208 that, in the
completed seal 32, forms a wall of the slit 38 (see FIGS. 6A 7B). A
flange portion 210 is also integrally molded into both preforms
202. The sides of the flange portion 210 are preferably set back
from the upper face of the planar portion 208, to provide a space
for overmold material (discussed in further detail below) to flow
between and connect the flange portions 210. The molding of the
preforms 202 is accomplished using conventional techniques and
equipment, preferably by injecting a thermoset material into the
cavity formed between the mold pairs 204a, 204b and 206a, 206b and
heating the molds and/or material to the set temperature of the
specific material used. Pressure may be applied as needed to
prevent material from leaking between the halves of the mold.
After this initial molding step, the mold halves 204a, 206a, with
the preforms 202a, 202b still positioned in them, are pressed
together with an overmold plate 212 positioned between the mold
halves, as depicted in FIGS. 19B 19C. The overmold plate 212, best
seen in FIG. 20 (with the outline of the preforms 202 also shown in
phantom), comprises a generally planar plate body 214 with an
overmold opening 216 cut into the body 214. The overmold opening
216 has a plan perimeter that conforms to the outer edges of the
completed seal 32, and may include a mandrel 218 that projects from
the lower portion of the opening 216 and forms the lead lumen 46
(see FIGS. 6A 7B) during the overmold process, as will be discussed
in greater detail below. The contacting faces of the mold halves
204a, 206a and the overmold plate 212 are advantageously
substantially planar. Thus the mold halves 204a, 206a, plate 212,
and preforms 202a, 202b define a mold cavity or volume 220 between
the walls of the overmold opening 216 and the outer edges of the
preforms 202a, 202b, and between the faces of the mold halves 204a,
206a.
With the mold apparatus (mold halves 204a, 206a and overmold plate
212) arranged as shown in FIG. 19C, additional thermoset material
is injected into the mold apparatus to fill the mold cavity 220 and
form the remainder of the seal 32. Preferably, the additional
material is injected soon (i.e., a few seconds) after the preforms
202 are molded and while they are still somewhat hot from the
initial molding. The additional material injected into the mold
cavity 220 bonds to the edges of the preforms 202 and forms the
edges of the slit 38 in the completed seal 32. In other words, the
remainder of the seal is overmolded onto the "sandwich" of preforms
202. Preferably, the preforms 202 are pressed together with
sufficient force during the overmolding process to prevent the
additional material from migrating between the contacting surfaces
of the preforms 202. This preserves the patency of the slit 38 by
preventing the contacting faces of the preforms 202 from bonding to
each other during the overmold step.
The overmold plate 212 may be made with a thickness approximately
the same as that of the "sandwich" of preforms 202a, 202b to define
a mold cavity 220 that, as described above, comprises the open
space between the walls of the overmold opening 216 and the outer
edges of the preforms 202a, 202b, and between the faces of the mold
halves 204a, 206a. This overmold opening thus also has a thickness
approximately equal to that of the preform sandwich, and all or
nearly all of the overmold material injected therein bonds only to
the edges of the preforms 202a, 202b. In an alternative embodiment,
the overmold plate 212 may have a thickness greater than the
preform sandwich. This thicker, alternative overmold plate thereby
defines a mold cavity that also includes open space that is created
between the mold halves 204a, 206a and the outer (i.e., facing away
from the slit in the completed seal) faces of the preforms 202a,
202b. The mold halves 204a, 206a are preferably configured with
projections, ridges, channels, gaps or the like to create such
space during this alternative overmold step while pressing the
preforms together as may be needed during the overmold.
Accordingly, in this embodiment the overmold material bonds to both
the edges and to the outer faces of the preforms 202a, 202b. In
other words this alternative overmold step involves injecting the
overmold material into a mold cavity that surrounds most or all of
the preform sandwich, rather than overmolding to the only the edges
of the preforms.
It is preferred that the material added in the overmold step is
similar to that utilized in molding the preforms 202; however, in
other embodiments the preform material and the overmold material
may comprise different but nonetheless suitable materials for
manufacturing the seal, as discussed above. Therefore as used
herein "a flexible material" refers to any material selected from
the class of suitable seal materials as disclosed.
After the overmolding is complete, the mold halves 204a, 206a are
removed from the seal plate 212, which now contains a substantially
completed seal 32, as seen in FIGS. 19D 19E. The completed seal 32
is easily removed from the seal plate 212, and the seal thus formed
comprises, as discussed above, a unitary mass of molded material
with the slit arranged within it.
Although this invention has been disclosed in the context of
certain preferred embodiments and examples, it will be understood
by those skilled in the art that the present invention extends
beyond the specifically disclosed embodiments to other alternative
embodiments and/or uses of the invention and obvious modifications
and equivalents thereof. Thus, it is intended that the scope of the
present invention herein disclosed should not be limited by the
particular disclosed embodiments described above, but should be
determined only by a fair reading of the claims that follow.
* * * * *